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临床试验/CTRI/2024/11/076315
CTRI/2024/11/076315尚未招募4 期

EFFICACY OF SUPRAINGUINAL VS INFRAINGUINAL APPROACH OF FASCIA ILIACA COMPARTMENT BLOCK FOR TOTAL DURATION OF ANALGESIA IN FEMUR FRACTURE SURGERY:A RANDOMIZED DOUBLE BLIND CLINICAL STUDY.

Government Medical College Baroda1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Duration of analgesia using VAS score

研究概览

简要总结

Our goal of study is to compare two different approaches of ultrasound guided regional block for total duration of analgesia in femur fracture surgery.

70 patients will be randomly divided into two group who are posted for femur fracture surgery under spinal anaesthesia

in one group , ultrasound guided  suprainguinal approach of fascia iliaca compartment block given 20 minutes before spinal anaesthesia pre operatively.

In second group, ultrasound guided infrainguinal fascia iliaca compartment block given 20 minutes before spinal anaesthesia pre operatively

Duration of analgesia will be assessed using  VAS score till 48 hours as a primary outcome.

As a secondary outcome, Total number of dose of rescue analgesia given in 48 hours post procedural, ease of positioning for spinal anaesthesia EOSP SCORE, vitals parameter at timely interval till 48 hours,and if any complication then noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing Fracture femur surgery under subarachnoid block & likely to have pain while positioning
  • Patients conformed to American Society of Anaesthesiologists (ASA) physical status I- III in preoperative assessment
  • Ability to follow the study protocol
  • Patient able to give written and informed consent.
  • Patient able to understand VAS regarding assessment of pain.

排除标准

  • Patients with contraindication to subarachnoid block .
  • Patient with significant history of drug and alcohol abuse
  • Pre-existing lower extremity neuromuscular disorders
  • Patients with multiple fractures
  • Local infection over the injection site
  • Allergy or contraindications to the drugs used in the study ( local anaesthetics, NSAIDs, Steroid )
  • Patients with other severe comorbid conditions like Diabetes Mellitus, Hypertension, IHD, Bronchial asthma, COPD, neuromuscular and musculoskeletal disease
  • Chronic opioid use.

结局指标

主要结局

Duration of analgesia using VAS score

时间窗: till 48 hours

次要结局

  • 1. Total number of rescue analgesics consumption in 48 hrs.(2. To assess ease of spinal positioning EOSP (EASE OF SPINAL POSITION SCORE))

研究者

发起方
Government Medical College Baroda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DIVYA GAJRA

SSG HOSPITAL, GOVERMENT MEDICAL COLLEGE BARODA

研究点 (1)

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